# K040854: West Nile Virus Igm Capture Elisa

- Pathway: 510(k) (Traditional)
- Applicant: Focus Technologies, Inc.
- Decided: Jun 30, 2004 after 90 days
- Product code: NOP (Elisa, Antibody, West Nile Virus)
- Device class: 2
- Regulation: 21 CFR 866.3940
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K993724 (2000). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K913618: Arbovirus Igm Ifa Test, Hillcrest Biologicals (1992) Summary page 1.
- K993724: HSV-2 Elisa Igg, Model EL0920G, Mrl Diagnostics (2000) Summary page 1.
- K031952: West Nile Virus Igm Capture Elisa, Model EL0300M, Focus Technologies, Inc. (2003) Summary page 1.
- (no number) CDC West Nile Virus IgM Capture ELISA: named in the summary without a submission number
- (no number) West Nile Virus Plaque Reduction Neutralization Test: named in the summary without a submission number

## Most influential descendants
- K153308: EUROIMMUN Anti-West Nile Virus ELISA (IgM) (2016), 0 descendants of its own

## Indications for use
The Focus Technologies West Nile Virus IgM Capture ELISA is intended for qualitatively detecting IgM antibodies to West Nile virus in human serum. In conjunction with the Focus Technologies West Nile Virus ELISA IgG, the test is indicated for testing persons having symptoms of meningioencephalitis, as an aid in the presumptive laboratory diagnosis of West Nile virus infection. Positive results must be tested using the background subtraction method (either on the initial test or on a repeat test). Positive results must be confirmed by neutralization test, or by using the current CDC guidelines for diagnosing West Nile encephalitis. This test is not intended for self-testing, and this test is not FDA cleared nor approved for testing blood or plasma donors. Assay performance characteristics have not been established for automated instruments.

Source page: https://510kreport.com/device/K040854
Methodology: https://510kreport.com/methodology